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临床试验/NCT03518879
NCT03518879已完成不适用

The ASTHMA-Educator: A Novel Algorithmic Software Tool to Help Manage Asthma

Montefiore Medical Center2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Change from baseline asthma control to 2, 4, and 6 months

研究概览

简要总结

Through this study, the investigators developed the ASTHMA-Educator mobile application, and evaluated its use among adult asthma patients at Montefiore.

详细描述

Through this study, the investigators developed the ASTHMA-Educator mobile application, and evaluated its use through 2 phases: 1) Phase 1 = process outcomes evaluation with 30 patients); and 2) Phase 2 (longitudinal clinical evaluation with 40 patients receiving the intervention at baseline, 2 months, 4 months, and 6 months). The study's primary outcome is asthma control.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (>18 years) with: (a) severe asthma (i.e. at least one asthma-related ED visit and/or hospitalization in the previous year); (b) access to a smartphone with short message service (SMS) capability; (c) English speaking; (d) able to give informed consent.

排除标准

  • (a) use of oral corticosteroids in the 2 weeks prior to the baseline visit; (b) pregnancy; (c) severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol; and (d) patients that previously received the ASTHMAXcel application.

结局指标

主要结局

Change from baseline asthma control to 2, 4, and 6 months

时间窗: Baseline, 2 months, 4 months, 6 months

Asthma symptom burden as measured by the Asthma Control Test

次要结局

  • Change from baseline asthma knowledge to immediately post-intervention, 2 months, 4 months, and 6 months(Baseline, immediately post-intervention, 2 months, 4 months, 6 months)
  • Patient satisfaction measured by the Client Satisfaction Questionnaire-8(Immediately post-intervention at the baseline visit, 2 months, 4 months, 6 months)
  • Time spent in using the mobile application(Immediately post-intervention at the baseline visit)
  • Asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)(Baseline, 2 months, 4 months, 6 months)
  • Asthma hospitalizations(Baseline, 2 months, 4 months, 6 months)
  • Asthma emergency department visits(Baseline, 2 months, 4 months, 6 months)
  • Asthma-related steroid courses(Baseline, 2 months, 4 months, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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